Safety and Behavioral Pharmacology of Cannabichromene as an Adjunct to Rheumatoid Arthritis Treatment; Effects on Inflammatory Markers and Rheumatoid Arthritis Disease Activity
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Incidence of Observed Adverse Events
研究概览
简要总结
For this quantitative study, the investigators will collect data on human safety and side-effects of Cannabichromene (CBC) and whether CBC reduces blood inflammatory markers and Rheumatoid Arthritis (RA) disease activity. The participants will participate in an ABAB design with 2 doses of CBC across the A phases. They will attend 5 in-person clinic visits where they will have physical evaluations, complete self-report forms, and have blood drawn for the following tests: hs-CRP, ESR, IL-6, TNF, Complete Blood Count [CBC], and CMP.
详细描述
Due to their anti-inflammatory effects, cannabinoids have been considered as a potential therapy for the treatment of rheumatic diseases in humans. However, there is not yet significant evidence for the efficacy of cannabinoid-based treatments for rheumatoid arthritis, even though it is included in the list of eligible conditions for medical cannabis in Canada and many US states. In this study, the investigators propose to examine the safety and human behavioral pharmacology of CBC:
No statistical hypotheses have been developed for Aims 1 and 2 as they are descriptive in nature. Aim 3 has the statistical hypothesis embedded within it. These are reiterated below:
Aim 1: Assess human safety of CBC through a count of the number of treatment-related adverse events experienced by participants. This is a descriptive aim and therefore does not have an associated hypothesis.
Aim 2: Assess human safety of CBC through measurement of blood markers indicating organ function. This is a descriptive aim wherein the investigators will provide a qualitative description of changes in blood markers during treatment; it therefore does not have an associated hypothesis.
Aim 3: Determine if CBC reduces blood inflammatory markers and overall rheumatoid arthritis disease activity (as measured by the DAS28), across 2 dosages (400mg and 600mg CBC daily), each administered for an 8-week period. The investigators hypothesize that CBC will yield lower levels of inflammatory markers and overall disease activity during the treatment period and that levels of inflammatory markers will return to baseline at the 2-week follow-up for both of the doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to dose but will know they are all getting active product.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a current diagnosis of RA
- •Having stable treatment for at least 1 month prior to the study and being willing to continue that treatment for the duration of the study
- •Having some degree of disease activity present at research study intake (determined by research study personnel)
- •Able to read and speak English, and provide written consent
- •Not currently pregnant or planning to become pregnant during the trial
- •Not currently planning any surgeries during the course of the trial
- •Willing to use a form of birth control for the duration of the study (all participants will be required to use birth control for the duration of the study)
- •Willing to refrain from cannabis use (other than study provided CBC) over the course of the study
排除标准
- •Do not have a current diagnosis of RA
- •Has not received stable treatment for at least 1 month prior to the study or is unwilling to continue treatment for the duration of the study
- •No degree of disease activity present at research study intake (determined by research study personnel)
- •Under age 21
- •Unable to read and speak English, or provide written consent
- •Are currently pregnant or planning to become pregnant during the course of the trial
- •Unwilling to use a form of birth control during the duration of the study
- •Is planning a surgery during the course of their participation in the trial
- •Unwilling to refrain from cannabis use (other than study provided CBC) over the course of the study
研究组 & 干预措施
Study Group 1
Participants will be administered dose one (400mg CBC daily) for eight weeks, and at visit three they will receive dose two (600mg CBC daily) and will take it for eight weeks, concluding the study with another two-week washout period.
干预措施: Cannabichromene (Drug)
Study Group 2
Participants will be administered dose one (600mg CBC daily) for eight weeks, and at visit three they will receive dose two (400mg CBC daily) and will take it for eight weeks, concluding the study with another two-week washout period.
干预措施: Cannabichromene (Drug)
结局指标
主要结局
Incidence of Observed Adverse Events
时间窗: 20 Weeks
Observed Adverse events
Incidence of Serious Adverse Events
时间窗: 20 Weeks
Observed Serious adverse events
Incidence of Side-Effects Reported by Participants
时间窗: 20 Weeks
Participant self-report of side-effects
Description of Safety Focused Blood Markers (CMP)
时间窗: 20 Weeks
Safety focused blood marker levels aggregated through Comprehensive Metabolic Panel (CMP) during the treatment and post treatment phases.
Description of Safety Focused Blood Markers (CBC)
时间窗: 20 Weeks
Safety focused blood marker levels aggregated through Complete Blood Count (CBC) during the treatment and post treatment phases.
次要结局
- Number of Participants With CBC Treatment-Related Reduction of RA Disease Activity as Assessed by DAS28.(20 Weeks)
- Number of Participants With CBC Treatment-Related Reduced Inflammatory Blood Markers as Assessed by hs-CRP, ESR, IL-6, and TNF Tests.(20 Weeks)
研究者
Crystal Lederhos Smith
Assistant Professor
Washington State University